Surgical tool and method of use

ABSTRACT

A surgical tool incorporates a suture guide with an anchor driver supporting an anchor where the anchor is maintained at a distance from the suture guide until release of a detent mechanism. Thereafter, the anchor is allowed to move into proximity to the suture guide, fixing a suture supported by the suture guide to a substrate, the entire procedure being achievable with a single hand.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/551,705 filed on Aug. 26, 2019 which, in turn claims benefit of U.S.provisional patent application No. 62/724,599 filed on Aug. 29, 2018,and claims benefit of U.S. provisional patent application No. 62/722,976filed on Aug. 26, 2018; and the present application is a continuation ofU.S. patent application Ser. No. 16/551,705 filed on Aug. 26, 2019which, in turn is a continuation-in-part of U.S. patent application Ser.No. 16/206,736 filed on Nov. 30, 2018 which, in turn, is a continuationof international patent application PCT/US 2017/035792 having aninternational filing date of Jun. 2, 2017 and which PCT applicationclaims benefit of U.S. provisional patent application 62/344,489, filedon Jun. 2, 2016, and which PCT application claims benefit of U.S.provisional patent application 62/368,023 filed on Jul. 28, 2016, thedisclosures of all of the foregoing being herewith incorporated byreference in their entirety.

FIELD OF THE INVENTION

The present invention relates to a system, method and apparatus forfixturing tissue and, more specifically, to adjustable surgicaltenodesis fixturing.

SUMMARY

A wide variety of traumatic injuries can result in detachment ofligament and/or tendon from bone. In such circumstances, surgicalreattachment offers the potential for substantial recovery. Generally,reattachment surgery involves fixing a portion of the detached softtissue, e.g., ligament, tendon, to a relatively hard substrate such asbone. The soft tissue is typically placed in contact with a surface ofthe substrate at, or adjacent to, the point of detachment and mechanicalfixation is applied to hold the respective tissues in contact with oneanother while healing takes place.

Reattachment surgery can be accomplished both by open methods andarthroscopically, and a variety of systems and techniques exist toeffect the necessary tissue fixation. Regardless of the approach taken,however, precision of positional and tension control of the tissuesinvolved, and of any sutures used for placement and fixation, can have asignificant impact on achieving favorable outcomes. It is alsobeneficial to simplify procedures wherever possible, reducing time andpersonnel involved in the operation. The benefits to the patient ofreducing time of a procedure are widely known and the economic impact ofhaving an equally effective or better procedure performed in less timeand/or by fewer medical personnel is increasingly significant.

Through experience, careful analysis and creative effort, the inventorsof the present invention have identified an opportunity to provide fortissue fixation and developed novel improved systems methods andapparatus.

Achieving appropriate position and tension in the graft can be difficultin practice. Existing techniques include the fixation of suture to boneusing threaded or barbed anchors and coupling the suture to soft tissueusing surgical knots or knotless fixation. In the case of knotlessfixation, a suture maybe captured by an interference fit between asuture anchor and a region of surrounding bone. In other techniques,soft tissue is drawn into a prepared aperture in the adjacent substrateand pinned against a surface of that substrate by interference with asurface region of an anchor.

In certain procedures, once soft tissue has been attached to the suture,a distal end of the suture can be positioned so as to properly locatethe soft tissue with respect to the bone. Thereafter, a fixturingmechanism can be applied to ensure that this relationship is maintained.Preferably, the process will account for the fact that application ofthe fixturing mechanism may tend to change the position and/or tensionof a portion of the suture material.

The present invention includes an integrated surgical tool including ananchor driver and a guide portion. The guide portion is arranged toallow a user to position first and second materials (e.g. bone, softtissue or synthetic tissue or a device) in relation to one another andthen release the anchor driver so as to allow engagement of the anchordriver with one or more of the tissues and fixate the tissues together(e.g. ligament or tendon to bone). Depending on the particulararrangement of the surgical tool, the surgical tool will include asuture guide that positions a suture within a prepared bore of asubstrate bone material. The suture, having been attached to a softtissue or material, is then fixed in place with respect to the bone byreleasing the anchor driver portion and allowing a bone anchor coupledto the anchor driver to be fully engaged with the substrate bonematerial.

In other embodiments, direct tissue fixation for example, soft tissuewill be directly positioned and held in place by a guide portion of thesurgical tool. Once the soft tissue is positioned, an anchor guide isreleased and the anchor (anchor, suture anchor, soft tissue anchor,threaded device or driven in device) directly engages both the softtissue and underlying bone tissue to achieve effective fixation of thetwo materials.

Thus, in certain embodiments, the invention includes a surgical toolthat incorporates a suture guide and anchor driver supporting an anchorwhere the anchor is maintained at a distance from the suture guide untilrelease of a detent mechanism. Thereafter, the anchor is allowed to moveinto proximity to the suture guide, fixing a suture supported by thesuture guide to a substrate, the entire procedure being achievable witha single hand. In certain embodiments, the invention includes a surgicaltool comprising, a handle portion, said handle portion including adetent mechanism, a tissue positioning portion, said tissue positioningportion being releasably coupled to said handle portion through saiddetent mechanism; and a substrate anchor driver portion, said substrateanchor driver portion including a coupling feature for coupling saidsubstrate anchor driver portion to a substrate anchor, wherein saidhandle portion, said tissue positioning portion and said substrateanchor driver portion share a mutual longitudinal axis, and wherein saidtissue positioning portion and said substrate anchor driver portion aredisposed in controlled sliding relation to one another, subject tooperation of said detent mechanism.

In certain embodiments the invention includes a non-cannular or cannularhandle portion containing a push or sliding type button that is designedto allow or prevent rotation and axial movement of an inner shaft thatis housed within an outer shaft, such that the inner shaft can rotateand collapse within the length of an outer shaft.

The inner shaft has one or more detents, that the button described abovecan control, that allows the inner shaft to be fixed at one or morepoints along its length. Additionally, the inner shaft has a distal tipthat has an integral or detachable elongated eyelet that can accommodateone or more length(s) of suture.

In certain embodiments, the eyelet is oval shaped and designed to placethe suture at an effective depth within a socket or tunnel in bone. Thetip is designed to collapse within the cannulation of an implant made ofmetal, polymer or other biocompatibly suitable material and release thesuture captured by the eyelet in its original condition.

In certain embodiments, the eyelet is arranged to collapse as the anchoris screwed into the bone. The collapse of the eyelet releases the sutureand allows the inner shaft to be extracted from the implant. The outershaft has a proximal end that is fixed within the handle and a distalend that has a drive mechanism with a geometric shape designed to eitheradvance a cannular implant that has threads that allow it to be turnedin the prepared boney socket or tunnel, or of another type that allowsthe implant to be driven into the prepared socket or tunnel. Bothdesigns, and others described herewith, are purposed to capture andsecure one or more sutures against its length and the socket or tunnel.

Screwing or driving in the cannular implant into bone provides thenecessary mechanism to place and hold tissue into the desired position.The features of this design allow the user to place, tension and fixtissue to a boney surface. Unlike other designs, the user is notrequired to use two hands to deploy the anchor, freeing the other handto assist in other aspects of the procedure.

In still further embodiments, the driving apparatus is prepared asdescribed above. However, instead of an eyelet on the inner shaft, theapparatus features a polymer, or other suitable biocompatible material,washer designed to be releasably fastened to an inner shaft, which isinserted into soft tissue, e.g. biceps tendon.

The washer serves to increase the surface area of the inner shaft andhelp to prevent the tip from passing through the tissue further thandesired. Upon achieving the desired fixation described below, the innershaft and outer shafts are extracted from the patient, leaving thewasher trapped between the soft tissue and the tip of the fixationscrew.

Another iteration of the device includes an inner shaft that in additionto accommodating the washer above, includes an inner shaft with a slotor eyelet that allows the user to pass a suture or sutures through thesoft tissue and then pass the free ends of the suture through the eyeletor slot.

Once this step is completed, the user has the soft tissue firmlyattached to the device. This step adds improved ability to control andmanipulate the soft tissue. Like the embodiments described above, theouter shaft is used to propel a threaded or push-in type anchor in aboney socket where the soft tissue has been placed. The anchor createsan interference fixation, trapping the soft tissue within the preparedsocket. This design also can be used with a single hand, thus improvingits utility.

In light of the disclosure presented herewith, the invention includes incertain embodiments, an implant insertion system with an implant driver.The implant driver includes a first longitudinal cannular shaft having aproximal end and a distal end. First longitudinal cannular shaft alsohas a first longitudinal axis defined concentrically within the shaftbetween the proximal end and the distal end. The cannular shaft has acoupling feature adjacent to the distal end, where the coupling featureis arranged, configured and adapted to releasably support a sutureanchor. That is, in certain embodiments, a suture anchor is fixed on areleasable splined feature so that it is held in place until installedin a substrate such as bone, and then released from the splined featureas the cannular shaft is withdrawn.

The implant insertion system also includes a suture guide. The sutureguide includes a further longitudinal shaft with a proximal end, adistal end, and a second longitudinal axis defined concentrically withinthe shaft between the proximal end and the distal end.

As the implant insertion system is assembled, the second longitudinalshaft is installed slidingly within the cannular shaft. One of skill inthe art will thus appreciate that the the second longitudinal axis andthe first longitudinal axis are aligned with one another. Indeed,depending on the specific configuration of the cannular shaft and thefurther longitudinal shaft of the suture guide, the two longitudinalaxes will often be coincident—i.e., align with one another.

The implant driver also includes a suture loop feature. The suture loopfeature generally includes an aperture through which a portion of asuture is threaded or otherwise inserted so that the suture loop featurecontrols the suture and/or is slidingly coupled to the suture.Generally, the suture loop feature is disposed at the distal end of thesecond longitudinal shaft. In various embodiments, the suture loopfeature is integrally formed with the second longitudinal shaft. Inother embodiments, the suture loop feature is prepared independently andthen fasten to the distal end of the second longitudinal shaft. Thisfastening is accomplished with a combination of internal and externalthreads, with an interference fit, with a pin or dowel or other deviceinserted through a transverse bore spanning both the suture loop featureand a portion of the shaft, by welding the suture loop feature to theend of the shaft by, for example, resistance welding, arc welding, laserwelding, soldering, brazing, or any other fastening technique that isknown or becomes known in the art, or, for example, by the action of achemical or physical adhesive such as, for example and withoutlimitation, a polyacrylate adhesive.

In addition, in certain embodiments, the suture loop feature will beformed in situ on the end of the second longitudinal shaft by, forexample, powder metallurgical and/or sintering techniques, additivemanufacturing techniques such as, for example, 3D printing and/or insitu molding techniques such as, for example, metallic diecasting orpolymer injection molding. It will be appreciated by one of skill in theart that the foregoing are merely exemplary of a wide variety ofmanufacturing techniques that will be advantageously employed dependingon the particular requirements of a particular embodiment or applicationof the invention.

In certain embodiments, the suture loop feature includes a body portionhaving at least first and second surface regions, where the first andsecond surface regions taper towards the second longitudinal axis inproximity to a distal end of the suture loop feature. In other words,the suture loop feature will, in certain embodiments, be generallypointed, arriving at, for example, a sharp point, a rounded point, astub point, a small flattened surface, or any other configuration thatwill be found advantageous in particular circumstances. A cross-sectionof this point will be, in certain embodiments, a generally diminishingcircular cross-section. In other embodiments, this cross-section will bepolygonal (i.e. any polygon between triangle and a true circle,stellate, oval, flat oval (i.e., of the form of two semicirclesseparated by intervening line segments) or of any other form. Moreover,in various embodiments the taper will include one or more of linearregions and nonlinear regions so as to include, e.g., conical surfaceregions, semi ellipsoid surface regions, etc.

In certain embodiments, the suture loop feature will include first andsecond circumferential edges, spanned therebetween by an internalsurface region. Accordingly, the internal surface region defines aneyelet through the body portion of the suture loop feature. This eyelet,eye, or bore is arranged to receive a suture through its aperture in themanner discussed above and further illuminated below. In manyembodiments, the eyelet or aperture will be generally transverse to thesecond longitudinal axis, so that a suture enters the eyelet on one sideof the second longitudinal shaft and exits the eyelet on the other sideof that shaft. As noted above, in certain embodiments, the eyelet willbe oval-shaped. In other embodiments, the eyelet will be circular,polygonal, generally rectangular, or have any other configuration foundto be desirable in relation to particular application and circumstance.

As will be apparent in reviewing the attached figures, in certainembodiments, the body portion of the suture loop feature includes aspine portion on one side of the eyelet and a latch portion on anopposite side of the eyelet. One of skill in the art will appreciatethat this latch portion serves to releasably contain a portion of suturewithin the eyelet. Thus, the suture advantageously is coupled to theeyelet, and thus to the suture loop feature when desired and,thereafter, can be released from the eyelet by activation of the latchportion of the suture loop feature.

It will be appreciated that a wide variety of modes of operation will beemployed in latch portions prepared according to various aspects andembodiments of the invention. Thus, in certain embodiments, the latchportion will be formed of a material that is designed to deformelastically to allow passage of the suture into and/or out of the eyeletand thereafter to resume its earlier position (i.e., effectivelyre-closing the eyelet once the suture portion has passed into or out ofan aperture formed by displacement of the latch portion.

In other embodiments, the latch portion will be formed of a materialthat will tend to deform inelastically, or at least where it's elasticlimit will be exceeded by operation of the latch portion. Thus, forexample, in certain embodiments, a suture will be threaded through theeyelet and thereafter released from the eyelet by a substantiallyinelastic displacement of the latch portion. This transition will beeffected, in various embodiments by, for example, pulling the eyeletaway from the suture portion after the suture has been fixed in placeby, for example, the installation of an anchor. In other embodiments,displacement of the latch portion, and consequently opening of theeyelet and release of the suture, takes place in response to withdrawalof the suture loop feature proximally outward through a longitudinalbore of the cannular first longitudinal shaft.

In any event, it will be appreciated that in certain embodiments of theinvention, the latch portion will be arranged, configured and adapted totransition from a first state in which the eyelet is closed to a secondstate in which the eyelet is open. Accordingly, and as described above,in the first state the eyelet is adapted to capture a length of sutureslidingly therewithin, and in the second state said eyelet is adapted torelease a portion of the length of suture from the eyelet, and thus fromthe suture loop feature.

In certain embodiments, the implant insertion system will also include ahandle. The handle can have any of a wide variety of configurationsdepending on the conditions of a particular application. In certainembodiments, the handle will be generally cylindrical and may begenerally circularly cylindrical. Other cross-sections andconfigurations such as, for example, a T-handle, a pistol grip, a ballor generally spherical or ellipsoid handle, and/or a polyhedral handle,and or combinations thereof, will also be beneficially employed incorresponding embodiments.

In certain embodiments, the handle will be substantially fixedly coupledto the proximal end of the cannular implant driver shaft. Consequently,the handle will be configured, arranged and adapted to convey a manualtorque applied to the handle through the first longitudinal shaft andits coupling feature to the suture anchor. In other words, by pressingand twisting on the handle, the user is able to install an exemplarysuture anchor into a substrate such as bone or cartilage. Of coursealternative suture anchors will also be applicable including barbedsuture anchors and suture anchors with other surface features.

In certain embodiments, the implant insertion system will include adetent mechanism. The detent mechanism will generally, though notalways, be disposed within the handle of the apparatus. In suchembodiments, the detent mechanism is arranged and configured toconstrain a sliding and/or rotational motion of the second longitudinalshaft within the cannula of the implant driver shaft. This allows a userto control a location of the suture loop feature with respect to thedistal end of the first longitudinal cannular shaft. In other words, andas will be further described and illustrated below, in a firstoperational mode, the suture loop feature is extended distally away thesuture anchor mounted on the distal end of the cannular implant drivershaft.

Beneficially, in certain embodiments, the detent mechanism will bearranged so that a surgeon or other user can use the same hand forholding the handle of the implant insertion system and for activatingthe detent release (e.g., by depressing a pushbutton, pulling a triggeror sliding a slider) so that, once sutures and/or tissue are properlypositioned, the anchor can be advanced into the substrate bone so as tofix the suture and/or tissue in place.

It will be understood by one of skill in the art that the detentmechanism may allow the initial distance between the suture loop and thedistal end of the anchor to be preset at any of variety of desirabledistances.

The following description is provided to enable any person skilled inthe art to make and use the disclosed inventions and sets forth the bestmodes presently contemplated by the inventors of carrying out theirinventions. In the following description, for purposes of explanation,numerous specific details are set forth in order to provide a thoroughunderstanding of the present invention.

It will be apparent, however, to one skilled in the art, that thepresent invention may be practiced without these specific details. Inother instances, well-known structures and devices are shown in blockdiagram form in order to avoid unnecessarily obscuring the substancedisclosed. These and other advantages and features of the invention willbe more readily understood in relation to the following detaileddescription of the invention, which is provided in conjunction with theaccompanying drawings.

It should be noted that, while the various figures show respectiveaspects of the invention, no one figure is intended to show the entireinvention. Rather, the figures together illustrate the invention in itsvarious aspects and principles. As such, it should not be presumed thatany particular figure is exclusively related to a discrete aspect orspecies of the invention. To the contrary, one of skill in the art wouldappreciate that the figures taken together reflect various embodimentsexemplifying the invention.

Correspondingly, referenced throughout the specification to “oneembodiment” or “an embodiment” means that a particular feature,structure, or characteristic described in connection with the embodimentis included in at least one embodiment of the present invention. Thus,the appearance of the phrases “in one embodiment” or “in an embodiment”in various places throughout the specification are not necessarily allreferring to the same embodiment. Furthermore, the particular features,structures, or characteristics may be combined in any suitable manner inone or more embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows, in schematic side elevation, an exemplary surgicalapparatus prepared according to principles of the invention;

FIG. 2 shows, in schematic perspective view, a portion of an exemplarysurgical apparatus prepared according to principles of the invention;

FIG. 3A shows, in schematic perspective view, an exemplary suturecontrol tip of a surgical apparatus according to the invention in afirst close mode of operation;

FIG. 3B shows, in schematic perspective view, an exemplary suturecontrol tip of a surgical apparatus according to the invention in asecond open mode of operation;

FIG. 4 shows, in schematic perspective view, certain aspects of anexemplary suture control tip prepared as a discrete component, and anassociated portion of a suture guide shaft;

FIG. 5A illustrates a selected state of an exemplary method of employinga surgical tool prepared according to principles of the invention;

FIG. 5B illustrates a selected state of an exemplary method of employinga surgical tool prepared according to principles of the invention;

FIG. 5C illustrates a selected state of an exemplary method of employinga surgical tool prepared according to principles of the invention;

FIG. 5D illustrates a selected state of an exemplary method of employinga surgical tool prepared according to principles of the invention;

FIG. 5E illustrates a selected state of an exemplary method of employinga surgical tool prepared according to principles of the invention;

FIG. 6 shows, in flowchart form, certain portions of a method for usinga surgical tool according to principles of the invention;

FIG. 7A shows, in schematic front elevation, a further suture loopfeature for a surgical tool prepared according to principles of theinvention;

FIG. 7B shows, in schematic side elevation, a further suture loopfeature for a surgical tool prepared according to principles of theinvention;

FIG. 8 shows, in schematic front elevation, a further suture loopfeature for a surgical tool prepared according to principles of theinvention;

FIG. 9 shows, in schematic front elevation, a further suture loopfeature for a surgical tool prepared according to principles of theinvention;

FIG. 10A shows, in cutaway perspective view, a further surgical toolprepared according to principles of the invention in an extendedconfiguration;

FIG. 10B shows, in schematic perspective view, a further surgical toolprepared according to principles of the invention in a retracted view;

FIG. 11A shows, in schematic cross-sectional view, an exemplary state inan exemplary method of using a surgical tool;

FIG. 11B shows, in schematic cross-sectional view, an exemplary state inan exemplary method of using a surgical tool;

FIG. 11C shows, in schematic cross-sectional view, an exemplary state inan exemplary method of using a surgical tool;

FIG. 11D shows, in schematic cross-sectional view, an exemplary state inan exemplary method of using a surgical tool;

FIG. 11E shows, in schematic cross-sectional view, an exemplary state inan exemplary method of using a surgical tool;

FIG. 11F shows, in schematic cross-sectional view, an exemplary state inan exemplary method of using a surgical tool;

FIG. 11G shows, in schematic cross-sectional view, an exemplary state inan exemplary method of using a surgical tool;

FIG. 11H shows, in schematic cross-sectional view, an exemplary state inan exemplary method of using a surgical tool;

FIG. 11J shows, in schematic cross-sectional view, an exemplary state inan exemplary method of using a surgical tool;

FIG. 11K shows, in schematic cross-sectional view, an exemplary state inan exemplary method of using a surgical tool;

FIG. 11L shows, in schematic cross-sectional view, an exemplary state inan exemplary method of using a surgical tool;

FIG. 12 shows, in exploded view, an exemplary surgical tool according toprinciples of the invention;

FIG. 13 shows, in schematic cross-section, a handle portion of asurgical tool prepared according to principles of the invention; and

FIG. 14 shows, in schematic cross-section, a surgical tool preparedaccording to principles of the invention.

DETAILED DESCRIPTION

The following description is provided to enable any person skilled inthe art to make and use the disclosed inventions and sets forth the bestmodes presently contemplated by the inventors for carrying out theirinventions. In the following description, for purposes of explanation,numerous specific details are set forth in order to provide a thoroughunderstanding of the present invention. It will be apparent, however, toone skilled in the art that the present invention may be practicedwithout these specific details. In other instances, well-knownstructures and devices are shown in block diagram form in order to avoidunnecessarily obscuring the substance disclosed.

The term “proximal” as used herein refers to that end or portion whichis situated closest to the user of the device, farthest away from thetarget surgical site. In the context of the present invention, theproximal end of the implant insertion system of the present inventionincludes the handle portion.

The term “distal” as used herein refers to that end or portion situatedfarthest away from the user of the device, closest to the targetsurgical site. In the context of the present invention, the distal endof the implant systems of the present invention includes an anchorand/or other components configured and adapted to fit within thepre-formed implant-receiving poor, hole or socket in the substrate.

As noted above, the results of surgery directed to reattaching softtissue and bone are likely to be improved by increasing the accuracy ofrelative tissue positioning, and effectively maintaining this positiononce established. Moreover, to the extent that this work can becompleted by a single surgeon, efficiency and effectiveness are likelyto be improved. Thus, in certain aspects, the present invention includesystems apparatus and methods that provide enhanced control of a sutureduring positioning of a graft, include a suture tool arranged andconfigured and adapted for one-handed operation. As further describedbelow, the present inventors have developed new and useful apparatus andmethods for achieving these and other benefits.

In a first phase of operation, a surgical tool prepared according toprinciples of the invention is arranged and configured to have a firstportion which includes a bearing surface within a bore in a substrateosseous tissue. The bearing surface supports a portion of a suture insliding relation. By adjusting tension on a first end of the samesuture, the location of soft tissue previously coupled to a second endof the same suture can be adjusted.

Once a desirable relative configuration of tissues has been achieved, asecond phase of operation of the surgical tool can be effected to drivea bone anchor into the bore, capturing a further region of the suturebetween the anchor and the osseous tissue and effectively fixing aspatial relationship between the soft and osseous tissues.

During the first phase of operation, the bearing surface is maintainedrelatively distal to the anchor, which has been preloaded on theapparatus. As the second phase of operation is entered, a detent isreleased allowing a separation between the bearing surface and theanchor to be reduced. The structural relationships of the apparatus, andits components, as they exist within these two phases of operation, willbe further clarified in light of the following figures and description.

It should be noted that the present invention includes a surgical toolthat allows single-handed deployment of a suture or interference fixedtissue. Thus, a surgeon using a single hand can insert a suture guide orcaptured tissue within a prepared bore in a substrate. Thereafter,without removing his or her hand from the handle of the surgical tool,the surgeon can release a detent such that an anchor having a helicalthread, a barbed surface feature, a smooth surface for interference fit,or any other appropriate fixation feature, can be deployed to retain thesuture and/or soft tissue at the bore. This single-handed operationoffers unique benefits, allowing rapid and practical fixation of tissuewith limited personnel and within the constraints of space limitationsin proximity to the patient.

FIG. 1 shows, in schematic side elevation, a surgical tool 100 preparedaccording to principles of the invention. Surgical tool 100 includes ahandle member 102. The handle member is coupled to an anchor driver 104.The anchor driver 104 is cannular in form: that is, it includes atubular member having an external circumferential surface 103 disposedabout a longitudinal axis and a longitudinal bore therethrough. In theillustrated embodiment, both the external circumferential surface, andan internal circumferential surface defining the longitudinal bore ofthe cannular anchor driver 104 have a generally circular cross-section.It will be appreciated by one of skill in the art, however, thatalternative cross-sections for either or both of these surfaces arecontemplated within the present disclosure.

An exemplary anchor, 106 is shown as engaged with a spline coupling 108at a distal end 109 of the cannular anchor driver 104.

One of skill in the art will appreciate that in other embodiments of theinvention, the anchor driver will not include any spline feature, butwill include other features or arrangements for coupling to the anchor.Thus, in certain embodiments, the anchor driver and anchor will havecomplementary helical threads. In still other embodiments, the anchordriver and anchor will have substantially smooth surfaces retainedadjacent to one another by an interference fit. In still otherembodiments, an adhesive material will retain the anchor driver andanchor in temporary connection to one another.

A suture guide shaft 110 is disposed coaxially within a longitudinalbore of the anchor driver 104. A distal end 109 of the suture guideshaft 110 includes a suture guide assembly 112.

FIG. 2 shows a detailed view 200 of the suture guide shaft 110 andsuture guide assembly 112 of FIG. 1 . In the illustrated embodiment, thesuture guide assembly 112 includes a washer 202 supported on a shouldersurface region (not visible) of the suture guide shaft 110 and a sutureguide feature 204 integrally formed on a distal end 206 of the sutureguide shaft 110. The suture guide feature 204 includes a spine portion208 disposed between a nose portion 210 and the shoulder surface regionof suture guide shaft 110. The suture guide feature 204 also includes agate portion 212.

FIG. 3A shows a further detailed view 300 of the suture guide assembly112 of FIGS. 1 and 2 in a closed configuration. In this illustration,the shoulder surface region 302 is clearly visible. As discussed above,this shoulder surface region 302 is well adapted to support a washer(not shown).

It will be understood by one of skill in the art, however, that otherembodiments of the invention will not include the washer and stillfurther embodiments of the invention will have no shoulder surfaceregion.

In the embodiment illustrated, the suture guide feature 304 includes aspine portion 306 disposed between the shoulder surface region 302 and anose portion 308. As shown, the nose portion is disposed at a distal end310 of the suture guide feature 304.

A gate portion 312 of the suture guide feature 304, includes an internalsurface region 314. Internal surface region 314 is disposed in generallyspaced relation to a corresponding internal surface region 316 of thespine portion 306.

In the illustrated configuration of FIG. 3A, the gate portion isdisposed in an inward-deflected arrangement so that a generally closedinternal surface 318 is formed by internal surface region 314, internalsurface region 316, and the intervening surface regions. It is readilyapparent that the internal surface region 318 defines an aperture 320 ofthe suture guide assembly 112. One of skill in the art will readilyappreciate that this aperture 320 is closed, and therefore adapted tocontain a portion of a suture therewithin so that the suture (not shown)and suture guide feature 304 are mutually coupled to one another.

In contrast, FIG. 3B shows a further detailed view 340 corresponding todetailed view 300 of FIG. 3A, except that gate portion 312 of the sutureguide feature 304 is disposed in an outward-deflected arrangement.Consequently internal surface region 318 is not contiguous, but open 342at a distal end of aperture 320. Therefore, aperture 320 is open andwill allow the release of any suture disposed therewithin, such that thesuture guide feature 304 and the suture (not shown) are decoupled.Accordingly, as will be understood by one of skill in the art, thesuture guide may be retracted once the suture has been fixed in place.

A method of using the suture guide assembly of FIGS. 1, 2 and 3 will bereadily understood by one of skill in the art upon review of the furtherdescriptions and figures provided below in relation to someone differentembodiments of the invention. In particular, it will be well understoodthat the present invention is well adapted to use in positioning andfixing tissue to a substrate such as bone or cartilage employing asuture, as shown, for example, in FIGS. 5A-6 below. The samearrangement, optionally including a washer such as washer 202, will beemployed in fixturing tissue directly to a substrate as shown, forexample, in FIGS. 10A-11H below.

In certain embodiments of the invention, the gate portion 312 of thesuture guide feature 304 will be urged to transition from the closedconfiguration of FIG. 3A to the open configuration of FIG. 3B by tensionapplied to the suture, and therefore to the internal surface region 314upon withdrawal of the suture guide shaft 322 axially 324 through acannular shaft of an anchor driver (e.g. 104 as shown in FIG. 1 ).

In certain embodiments of the invention, the resulting outward motion ofthe gate portion 312 will be a temporary transition. That is, if thegate portion is formed of a generally elastic material, and if theelastic limit of the gate portion material is not surpassed, the gateportion will tend to return to the closed configuration of FIG. 3A,after the suture portion has been released.

In other embodiments of the invention, the outward passage of the suturematerial will tend to exceed the elastic limit of the gate portionmaterial and thus permanently deform the gate portion such that the gateportion will tend to remain in the configuration of FIG. 3B as thesuture guide shaft 322 is withdrawn.

Accordingly, it will be appreciated by one of skill in the art thatvarious embodiments of the invention will include a variety of materialshaving a corresponding variety of elastic limits, tensile andcompressive strength, chemical characteristics and other features chosenfor optimal performance when employed in a particular application of thepresent invention. In particular, it will be appreciated that in certainembodiments, washer 202 of FIG. 2 will include a poly-ether-ether-ketone(PEEK) material. In other embodiments of the invention, washer 202 willinclude one or more of titanium and stainless steel.

More generally, it will be appreciated that any portion of an embodimentof the present invention will, as appropriate, include one or more ofnatural and synthetic polymers including, for example,poly-ether-ether-ketone (PEEK); reinforced polymer materials includingreinforcing sheets, particles and fibers of, for example, one or moreof, carbon fibers, carbon nano-materials, glass fibers and metallicfibers; precious metals, stainless steel, titanium and other metals;porcelain, alumina and other ceramics including, for example, aluminumoxide, calcium oxide, calcium phosphate hydroxyapatite, and zirconium.

In addition, it will be appreciated that while gate portion 312 of theinvention embodiments shown in FIG. 3 is integrally formed of the moreor less elastic or inelastic material of suture guide shaft 322, inother embodiments, the gate portion will be formed as a discretecomponent.

In still other embodiments, the gate portion 312 will be formed of ashape-memory alloy of any appropriate composition now known or yet to bediscovered in the art, that allows the gate portion 312 to desirablytransition from the closed configuration of FIG. 3A to the openconfiguration of FIG. 3B in response to a change in temperature of theapparatus. This change in temperature may occur according to a changingenvironment of the apparatus, or may occur in response to, for example,a heating or cooling element disposed in direct or indirect thermalcontact with the gate portion 312.

FIG. 4 shows a still further embodiment 400 of the invention in whichthe suture guide portion 402 is formed as a discrete element. In theillustrated exemplary embodiment, suture guide 402 includes a couplingportion 404. As shown, coupling portion 404 includes an externallythreaded portion 406 adapted to be threadingly coupled to acorresponding internally threaded bore 408 of a suture guide shaft 410.

In other embodiments of the invention, the gate portion 412 (or 312, asshown in FIGS. 3A and 3B) is prepared including a discrete component, asopposed to an integrally formed portion. In certain embodiments, adiscrete elastic element, e.g., a coil spring or a leaf spring, isdisposed and configured to urge the gate portion into the closedconfiguration illustrated in FIG. 3A.

Referring again to FIG. 1 , and as will be further discussed below, alongitudinal displacement of suture guide shaft 110 with respect to thecannular anchor driver 104 is controlled, in part, by a suture guiderelease button 118.

FIG. 5A-FIG. 5E illustrate selected states of an exemplary method ofemploying a surgical tool prepared according to principles of theinvention. FIG. 5A shows, in schematic form, a portion of a bone orother substrate medium 502. Adjacent a surface region 504 of the bone502 is a portion of a detached ligament 506. In anticipation ofreattachment of the ligament, a bore 508 has been drilled throughsurface region 504 and into the substrate bone 502.

Referring to FIG. 5B, in preparation for reattachment, the ligament 506is pierced 510 and a suture 512 is drawn through the ligament as shown.Two portions of the suture 514, 516 are disposed through an aperture(e.g., 320 of FIG. 3 ) of a suture guide 518, the suture guide beingdisposed at a distal end of a surgical tool 520.

As illustrated, the surgical tool 520 is configured in an extendedconfiguration (consistent with the arrangement illustrated in FIG. 10A).Consequently a distance 522 between the suture guide 518 and a distalend of a bone anchor 524 is relatively long. Moreover, while the sutureanchor is readily rotated about a longitudinal axis with respect to thebone anchor 524, distance 522 is substantially (though temporarily)fixed.

Consequently, applying a longitudinal force 526 to the surgical tool 520tends to urge the suture guide 518 into the bore 508 and towards adistal end thereof 528.

As illustrated in FIG. 5C, because the suture portions 514, 516 aredisposed through the aperture of the suture guide 518, urging the sutureguide 518 into bore 508 tends to draw corresponding regions 530, 532 ofthe suture into the bore 508. Concurrently, this motion of the surgicaltool 520 brings the distal end of bone anchor 524 adjacent the surfaceregion 504 of the bone at the mouth of the bore 508 where it passesthrough that surface region. By maintaining tension 534 on the sutureportions 514, 516 on the side of the suture guide 518 opposite to theligament 506, this motion can further cause a proximal end 538 of theligament 506 to be displaced 540 towards the mouth of the bore.

By manipulation of tension 534 on the suture portions, and consequentadjustment of the position of the longitudinal suture with respect tothe suture anchor, accurate and effective positioning of the ligament506 with respect to the surface 504 of the bone 502 can be achieved.Moreover, this can be accomplished by a single individual using twohands.

That same individual, without assistance and using a single hand, canthen press the release button (element 118, FIG. 1 ) and release thedetent controlled by the release button while concurrently rotating ahandle of the surgical tool 520. Rotation of the handle, which isrotationally fixed with respect to the cannular anchor driver 540, andtherefore with respect to the bone anchor 524, causes a correspondingrotation of the bone anchor 524. By combining this rotational motionwith an application of longitudinal force 542 external helical threadson the bone anchor 524 can be made to engage with the internal surfaceof bore 508 and thereby advance the bone anchor 524 into the bore 508.

One of skill in the art will appreciate that, while a bone anchor 524,exhibiting external helical threads is shown for illustrative purposesin FIGS. 5A-5E, other anchors known in the art, or that may become knownin the art, may likewise be applied within the scope of the invention.Thus, for example, a barbed anchor, rather than a threaded anchor may beemployed. In addition, an anchor may be employed that incorporatesneither threads nor barbs, but is fixed within a bore by, for example,an interference fit. Likewise, an elastic retainer, an adhesivelyretained stopper, or any other retaining device appropriate to theparticular circumstances will be applied and considered to be within thescope of the invention.

As illustrated in FIG. 5D, further rotation 542 of the cannular anchordriver 540 causes the bone anchor 524 to be fully driven into the bore508. This tends to trap the suture portions 514, 516 firmly againstrespective internal surface regions of the bore 508, thereby preventingdisplacement of the ligament 506. Once driving of the bone anchor 524 iscomplete, tension may be applied 544 to the surgical tool 520.

Referring to FIG. 5E, one sees that this tension results in the splinefeature 550 of the cannular anchor driver 540 disengage from the boneanchor 524 and allow the surgical tool 520 to be withdrawn. As the toolis withdrawn, a portion of the suture 552 previously disposed within theeyelet 554 of the suture guide (suture loop) passes through an openingin the eyelet of the suture loop formed by operation of the gate portionof the suture loop feature. This allows the suture guide to release thesuture portion 552 and permits the withdrawal of the surgical tool 520described above.

FIG. 6 shows, in flowchart form, certain portions of a method 600 forusing a surgical tool according to principles of the invention. In theillustrated embodiment, the method includes determining a ligamentfixation location 602 with respect to an underlying substrate such asbone and drilling an anchor bore in the bone 604 to receive a boneanchor and a length of suture. A length of suture is coupled to aligament or other soft tissue by, for example, threading through thetissue with a needle 606. A portion of the suture is coupled to a sutureguide by, for example, threading the suture through an aperture of agenerally toroidal region the suture guide 608.

The suture guide and suture are manipulated, with the application ofappropriate pressure and tension (as would be understood by one of skillin the art) to insert the extended suture guide 612 into the boredrilled at step 604. Further application of pressure to the suture guideand tension on the suture, as well as direct manipulation of the softtissue and underlying substrate allows finalization of the ligamentlocation with respect to the bone 614.

While holding the suture in place, a release mechanism of the surgicaltool is activated. This release mechanism releases a detent that couplesthe suture guide to a balance of the surgical tool 616. This release ofthe detent mechanism allows the surgical tool to advance a bone anchorsupported by the surgical tool to be advanced 618 towards and into amouth of the bore prepared at step 604. In certain embodiments of theinvention, the bone anchor will contact the underlying bone and even beadvanced by rotation or pressure into the bore before any release of thedetent mechanism.

Rotation of a handle of the surgical tool conveys a torque through thehandle, through an anchor driver, through a spline feature and into thebone anchor so that the bone anchor threads engage an internal surfaceregion of the bore 620. Further rotation of the handle advances the boneanchor into the bore until the anchor is fully inserted at itsdestination 622.

Thereafter, the handle of the surgical tool is withdrawn, disengagingthe spline coupling from the now-inserted bone anchor. As the surgicaltool is withdrawn, the portion of the suture that was disposed withinthe suture guide passes through a slot in the suture guide 624. Thisallows complete withdrawal of the surgical tool and leaves the suturecompressed and fixed to the internal surface of the bore by the insertedbone anchor.

FIG. 7A shows, in schematic front elevation, a suture loop feature of analternative embodiment of a suture guide prepared according toprinciples of the invention. Suture loop feature 700 is formed as adiscrete element. It includes a coupling portion 702 that, in theillustrated embodiment, is adapted to be received into a female threadedaxial receptacle at the distal end of a suture guide shaft. The sutureloop portion 700 includes a spine portion 704 and a gate portion 706. Aninternal surface region 710 of the suture loop portion defines an eyelet712 that is adapted to receive a portion of a suture slidinglytherethrough. As will be further discussed below, and end region 708 ofgate portion 706 is disposed in proximity to a further gate portion 710of the spine portion 704, effectively closing the eyelet when the sutureloop portion 700 is in a first closed state.

FIG. 7B shows, in schematic side elevation, a further aspects of thesuture loop feature 700 of FIG. 7A. In particular, a portion of spineportion 704 is visible, as is a portion of gate portion 706. It will beapparent upon inspection that a first surface region 716 of the spineportion 704 is disposed adjacent to or in contact with a second surfaceregion 718 of gate portion 706. In certain embodiments, it will bepossible to load a portion of a suture into the eyelet 712 of the sutureloop feature 700 by sliding the portion of the suture through a slot 720between surfaces 716 and 718. The slot 720 is either continuouslypresent between the two surface regions 716 and 718, or is formed by amore or less elastic displacement of the two surfaces apart from oneanother, either by insertion of the suture or by application of externalforces (with or without a tool). Thus, a suture may be loaded into theeyelet 712 without threading and end of the suture through that eyelet.

Thereafter, the suture may be released from the eyelet by theapplication of further forces, as described above, that result in theelastic or inelastic displacement of the gate portion (or the spineportion). Accordingly, the suture loop portion may be withdrawn from thesuture anchor site, leaving behind the suture, the anchor and therespective tissues desirably affixed to one another.

FIG. 8 shows a further suture loop feature 800 that is functionallysimilar to that of FIGS. 7A and 7B, but having a more or less ovaleyelet and a generally tapered or pointed aspect. Like the suture loopfeature 700, suture loop feature 800 can be loaded with a suture withoutthreading the suture through the eyelet.

FIG. 9 shows a still further suture loop feature 900. Like suture loopfeature 800, suture loop feature 900 has a more or less oval eyelet anda generally tapered or pointed aspect. In particular, suture loopfeature 900 includes a spine portion 902 and a gate portion 904. Unlikethe embodiments of suture loop feature 700 and suture loop feature 800,however, an interface between the spine portion 902 and the gate portion904 includes respective end surface regions thereof 906, 908 that arebutted against one another. As illustrated, respective end surfaceregions are curved.

In certain embodiments of the invention, respective recesses 910, 912are provided in the spine portion 902 and gate portion 904 that increaseelastic flexure in proximity to the recesses. Consequently, a portion ofa suture urged inwardly in region 914 will cause flexure of the spineportion 902 so that the suture can pass into the eyelet. Similarly,outward force applied at region 918 will cause a corresponding flexureof the gate portion 904 in the vicinity of the recess 912 so that thesuture can escape from the eyelet 916.

FIG. 10A shows, in cutaway perspective view, a further surgical tool1000 prepared according to principles of the invention. Like the variousembodiments described above, exemplary surgical tool 1000 includes acannular anchor driver 1002 coupled through spline features 1004 to abone anchor 1006. Disposed within and through a longitudinal cannula ofthe cannular anchor driver 1002 and the bone anchor 1006 is a shaft1008. The shaft 1008 defines a longitudinal axis 1010.

Near a distal end 1012 of the shaft 1008, a generally toroidal bearingwasher 1014 is disposed coaxially about the shaft 1008. The generallytoroidal bearing washer 1014 is supported on shaft 1008 by a snug butslidable interface 1016 between an internal circumferential surface ofthe washer 1014 and a corresponding external circumferential surface ofthe shaft 1008. In certain embodiments, a cross-section of the shaft1008 is circular. It will be appreciated, however, by one of skill inthe art, that in any of the embodiments disclosed in this application,other cross-sections are contemplated to be within the scope of theinvention. Such other cross-sections will include, in variousembodiments and without limitation, polygonal, elliptical and otherwisearcuate cross-sections.

A first relatively proximal circumferential surface region 1018 of theshaft 1008 has a relatively large diameter 1020. A second relativelydistal circumferential surface region 1022 of the shaft 1018 has arelatively small diameter 1024. A generally radial surface region 1026disposed between surface region 1018 and surface region 1022 defines ashoulder further supporting the washer 1014 and limiting its motion in aproximal direction along longitudinal axis 1010 by mechanicalinterference.

In the illustrated embodiment, a distal extremity 1028 of shaft 1008tapers to a point 1030. This taper is defined by an intermediate surfaceregion between circumferential surface region 1022 and point 1030. Aneyelet 1031, as described above, is visible adjacent the distal point1030. In reviewing the following description as related to FIGS.10A-11L, one of skill in the art will understand that this pointed endmay be used without employing a suture and the presence of the eyelettherewithin will have no negative effect. That said, as discussed aboveand below in relation to short FIG. 11I-11L in certain applications andembodiments of the invention, a suture will be advantageously disposedwithin the eyelet to further enhance effectiveness of the inventiveapparatus and system.

In various respective embodiments, this intermediate surface regionincludes a substantially conical surface region, an elipto-conicalsurface region (i.e. generally conical, but with a convex or concavesurface curvature), a prismatic or pyramidal surface region includingone or more generally flat surface regions (e.g., as shown 1032), andany combination thereof, to provide, respectively, piercing and cuttingactions. In addition other modes of sharpening, such as and withoutlimitation, chisel sharpening, will be employed in correspondingembodiments of the invention, according to the requirements of aparticular application.

In light of the foregoing disclosure, the reader will appreciate thatthe surgical tool 1000 is shown in an extended configuration such thatdistance 1034 between washer 1014 and a distal end 1036 of bone anchor1006 is relatively long, as compared to the corresponding dimension ofthe same surgical tool when disposed in a retracted configuration. Sucha retracted configuration is illustrated in FIG. 10B. As drawn, wherethe surgical tool 1000 is in its retracted configuration, washer 1014 isdisposed relatively proximate to distal end 1036 of bone anchor 1006 anddistance 1038 is consequently relatively short.

FIGS. 11A-11H show, in schematic cross-sectional view, various states inan exemplary method of using a surgical tool 1100 similar to tool 1000of FIGS. 10A and 10B. FIG. 11A shows surgical tool 1100, a portion of adetached tendon 1102 and a portion of a bony substrate 1104 where thetendon is to be reattached. As illustrated, a bore 1106 has beenprepared in the bony substrate to receive a portion of the tendon and abone anchor 1108.

It will be noted that a distal end 1110 of the surgical tool is pointedfor piercing, and that a circumferential external surface 1112 of ashaft 1114 of the surgical tool 1100 (or of a separate tip on the shaft1114) supports a corresponding internal surface 1116 of a bearing washer1118. It will also be noted that the bearing washer 1118 is preventedfrom moving proximally along shaft 1114 by a shoulder feature 1120, andthat the surgical tool 1100 is disposed in an extended configuration (asdiscussed in relation to FIGS. 10A-10B).

FIG. 11B shows that the surgical tool 1100 has been advanced so thatdistal end 1110 has pierced the tendon 1102. According to an exemplarymethod, tool 1100 is urged forward longitudinally until a distal surfaceregion 1122 of bearing washer 1118 contacts a corresponding surfaceregion 1124 of tendon 1102.

FIG. 11C shows that surgical tool 1100 has been rotated 1126 about anaxis transverse to longitudinal axis 1128 of shaft 1114, and advanced1130 towards the prepared bore 1106. Tendon 1102 is consequently movedwith respect to bony substrate 1104 and stretched towards a desiredattachment location.

Thereafter, as shown in FIG. 11D surgical tool 1100 is counter-rotated1132 to bring longitudinal axis 1128 generally into alignment with alongitudinal axis of bore 1106.

Thereafter, surgical tool 1100 is advanced with a generally linearmotion in direction 1134 along longitudinal axis 1128 to draw a portion1136 of tendon 1102 into and towards the bottom surface 1140 of bore1106, as shown in FIG. 11E. Once the tendon portion 1136 has beenadvanced to a desired location within bore 1106, a detent of thesurgical tool is released. This allows relative longitudinaldisplacement of the bone anchor 1108 in direction 1134 with respect tothe substrate bone 1104 and the washer 1118.

FIG. 11F shows a state of the surgical tool, in which a distal end 1141of the bone anchor 1108 has been advanced into contact with a proximaledge 1142 of bore 1106 (i.e., the mouth of the bore), and into contactwith a surface region 1144 the tendon 1102. This brings helical threadse.g., 1146, of the bone anchor 1108 into an arrangement where rotationof the bone anchor 1108 about longitudinal axis 1128 causes the threadsof the bone anchor to further engage with the surrounding bone and softtissue so as to advance the bone anchor towards the bottom 1140 of thebore 1106.

FIG. 11G shows a condition of the assembly once the bone anchor 1108 hasbeen rotated until fully driven into the bore 1106, such that the distalend 1141 of the bone anchor 1108 is disposed in contact with a proximalsurface region 1148 of bearing washer 1118. Thereafter, as shown in FIG.11H, the surgical tool may be withdrawn in direction 1150 alonglongitudinal axis 1128.

This causes the respective spline features 1152, 1154 of the surgicaltool 1100 to disengage. The surgical tool is removed and the bone anchor1108 and tendon 1102, 1136 are fixed in place. One of skill in the artwill appreciate that this arrangement will hold a surface region 1156 ofthe tendon in direct contact with a corresponding surface region 1158 ofthe substrate bone, allowing regrowth and reattachment of the softtissue and bone.

Referring again FIGS. 10A and 10B one sees an apparatus with an eyeletthat, in addition to accommodating the washer above, includes an innershaft with a slot or eyelet that allows the user to pass a suture orsutures through the soft tissue and then pass the free ends of thesuture through the eyelet. Once this step is completed, the user has thesoft tissue firmly attached to the device. This step adds improvedability to control and manipulate the soft tissue.

While ligament and bone have been identified in the foregoing discussionfor illustrative purposes, one of skill in the art will appreciate thatany variety of soft tissues and hard tissues will be joined according tothe identified methods and using the identified apparatus in variouscombinations.

In an alternative arrangement, a surgical tool such as surgical tool1100 is configured to be employed by passing a suture through softtissue 1102, and wrapping the suture around a circumferential externalsurface 1112 of shaft 1114. The suture is then urged into bore 1106 andfixed in place by the application of the anchor 1108.

FIG. 11I shows the installation of such a suture prior to wrappingaround the circumferential external surface 1112. Moreover, and asdiscussed above, in certain embodiments an eyelet (as shown 1031 in FIG.10 above) is provided as part of a suture loop feature of the shaft1114. Thus, FIG. 11I shows a needle 1170 (or, e.g. a suture passer)passing a portion of a suture 1172 through an exemplary detached tendon1102.

FIG. 11J shows the suture 1172 passed through the tendon 1102 andwithdrawn from the surgical site. Thereafter, one portion 1174 of thesuture is installed within an eyelet 1176 and gentle tension is appliedas the suture guides the suture loop down to the end of the tendon 1102.As described above, the pointed end of the suture loop is pressed intothe tendon in anticipation of an interference fit fixation.

Thereafter an arthroscopic sliding knot 1180 is tied in the externalends 1174, 1178 of the suture and drawn down to the interface betweenthe tendon 1102 and suture loop apparatus as shown in FIG. 11K. Thistends to help secure the tendon 1102 to the end of the surgicalapparatus, and further makes suture ends 1174, 1178 available to assistin positioning of the soft tissue with respect to the prepared bore1128.

FIG. 11L shows an alternative arrangement in which the surgical knot1182 is tied prior to insertion of the suture loop into the tendon 1102.

FIG. 12 shows, in exploded perspective view, an exemplary surgical tool1200 prepared according to principles of the invention. The surgicaltool 1200 includes a handle member 1202. The handle member 1202 issubstantially fixedly coupled to a cannular anchor driver 1204 such thata longitudinal axis of the handle member and a longitudinal axis of thecannular anchor driver are substantially coincident.

The cannular anchor driver 1204 includes, on an external circumferentialsurface of its distal end, a spline feature 1206. The spline feature1206 is sized and arrange to couple with, and be complementary to, aninternal spline feature of a bone anchor 1208. The bone anchor 1208 isshown as having an external helical thread for engaging with an internalcircumferential surface of a bore in a substrate. One of skill in theart will appreciate that any of the bone anchors presented in thisapplication need not be helically threaded, but may include any of awide variety of bone anchors including, for example and withoutlimitation, a barbed bone anchor, an adhesively mounted bone anchor, andany combination thereof.

Disposed within a longitudinal cannula (or bore) of the cannularanchored driver 1204 is a suture guide shaft 1210. The suture guideshaft is substantially fixedly coupled, at a distal end thereof, to asuture guide 1212. The suture guide includes, at its distal end, agenerally toroidal feature 1214 such as, for example, an eyelet. Thetoroidal feature defines an aperture 1216 with an internal bearingsurface region for encircling and controlling a portion of a suture orother material.

The longitudinal axis of the suture guide shaft 1210 lies generallywithin a plane of the aperture 1216. A longitudinal axis of the aperturethrough the plane of the aperture is disposed generally transverse tothe longitudinal axis of the suture guide shaft 1210. When the sutureguide shaft 1210 is in use, it is disposed within the cannula of thecannular anchor driver 1204, such that the cannular anchor driver at thesuture guide shaft are arranged generally coaxial to one another.

In the illustrated embodiment, the suture guide shaft 1210 includes,near its distal end, an externally threaded coupling feature 1218 andsuture guide support shoulder 1217. These serve to substantially fixedlycouple the suture guide shaft 1210 to the suture guide 1212. One ofskill in the art will understand that, in various embodiments, thesuture guide shaft 1210 and suture guide 1212 will be coupled in anyeffective way known, or that becomes known, in the art. Moreover, incertain embodiments, the suture guide shaft 1210 and suture guide 1212will be integrally formed as a single component.

Also illustrated are components of a detent mechanism 1219 of thesurgical tool 1200. These include a release button member 1220, having agenerally planar upper surface region 1221 and a detent shaft 1222 witha generally cylindrical external surface region. A detent shaft relieffeature 1224 describes a recess formed in the detent shaft 1222. Therelease button member 1220 also includes a suture guide shaft aperture1226 disposed through the detent shaft 1222 within the detent shaftrelief feature 1224 and generally transverse to a longitudinal axis ofthe release button member 1220.

The handle member 1202 includes a detent shaft aperture 1228 with thelongitudinal axis generally transverse to the longitudinal axis of thesurgical tool handle member 1202. The detent shaft aperture 1228 isconfigured to receive the detent shaft 1222 slidingly therewithin. Adetent spring 1230 is sized and configured to be disposed within arecess 1232 arranged within the handle member 1202 coaxially arounddetent shaft aperture 1228. As will be evident to the reader, the detentshaft 1222 is sized and configured to be disposed within an internalregion defined by the detent spring 1230.

The illustrated detent spring 1230 is shown as a plurality of Bellevillewashers. One of skill in the art will appreciate, that otherconfigurations, including any spiral spring, elastomeric tube, or otherelastic member will be used in corresponding embodiments of theinvention according to the requirements of a particular application.

The recess 1232 is defined by an internal surface region of a sutureguide release button relief 1234, such that the release button member1220 can move radially into the handle by compression of spring 1230when an inward radial force is applied to upper surface region 1221.

A detent shaft retainer fastener 1236 is configured to be coupled to alower end of the release button member 1220 (e.g., by a threadedcoupling, a weldment, a chemical adhesive, etc.) so as to retain therelease button member 1220 and detent spring 1230 in place.

As illustrated, the suture guide shaft 1210 includes first 1238 andsecond 1240 capture relief features near a proximal end of the sutureguide shaft. The suture guide shaft 1210 also includes a tapered feature1242 immediately adjacent its proximal end. As will be further discussedand illustrated below, first 1238 and second 1240 capture relieffeatures are arranged and configured to be releasably captured at thedetent shaft relief feature 1224 when the suture guide shaft 1210 isdisposed within the suture guide shaft aperture 1226 of the detent shaft1222.

As illustrated, in certain embodiments a further sheath 1250 is disposedcoaxially around the outside of cannular anchor driver 1204.

FIG. 13 shows, in cross-section, a portion of an exemplary surgical tool1300 prepared according to principles of the invention. Surgical tool1300 includes a handle member 1302 with a detent shaft aperture 1304. Adetent member 1305 including a detent shaft 1306 is disposed coaxiallywithin the detent shaft aperture 1304. Transverse to the detent shaftaperture 1304, a cannular anchor driver 1308 is substantially fixedlydisposed coaxially within a further bore 1309 of the handle member 1302.

Slidingly disposed within a cannula 1310 of the cannular anchor driver1308 is a suture guide shaft 1311. The guide shaft is relieved at twolocations along its length; an extended guide shaft relief 1312, and aretracted guide shaft relief 1314. One of skill in the art will readilyunderstand that the guide shaft is adapted to be arrested in itslongitudinal motion by a detent mechanism of the handle at either of theextended guide shaft relief 1312 and the retracted guide shaft relief1314.

The suture guide shaft 1311, is rotatable within the cannula 1310 whencaptured by the detent mechanism at both of the extended configurationand the retracted configuration. That is, the handle member 1302 can beco-rotated with the cannular anchor driver 1308 about a longitudinalaxis common to the handle, the cannular anchor driver 1308 and thesuture guide shaft 1311 while the suture guide shaft 1311 remains staticand does not rotate.

In order to allow this relative rotation of the handle member 1302 andcannular anchor driver 1308 with respect to the suture guide shaft 1311,the cross-sections of the suture guide shaft 1311 and both the extended1312 and retracted 1314 reliefs of the suture guide shaft aresubstantially circular.

In other embodiments, the detent mechanism is arranged to preventrotation of the suture guide with respect to the cannular anchor driveruntil the detent mechanism is released.

The detent member 1305 includes a suture guide release button 1316. Oneend of a detent spring 1318 is located proximal to a lower surface 1319of the suture guide release button 1316. An opposite end of the detentspring 1318 is supported by a detent spring shoulder 1320. The detentspring 1318 is arranged to urge the lower surface 1319 of the sutureguide release button 1316 away from the detent spring shoulder 1320.This motion is limited by a detent shaft retainer fastener 1322 in amanner that will be evident to one of skill in the art.

Detent shaft 1306 includes a detent shaft aperture 1328 which is locatedsubstantially perpendicular to a longitudinal axis 1330 of the detentshaft 1306. By urging the lower surface 1319 of the suture guide releasebutton 1316 away from the detent spring shoulder 1320, the detent spring1318 tends to maintain circumferential edges 1324, 1326 of the detentshaft aperture 1328 in contact with corresponding edge regions of theguide shaft reliefs 1312, 1314 so as to temporarily substantially fixthe longitudinal position of the suture guide shaft 1311 with respect tothe handle 1302 and cannular anchor driver 1308.

It will be noted that a proximal end 1332 of the suture guide shaft 1311includes a generally conically tapered region 1334. This conicallytapered region 1334 facilitates initial insertion of the suture guideshaft 1311 into the apparatus and past edge 1324 of the detent shaftaperture 1328.

Upon inspection, it will be clear to one of skill in the art that, whenthe surgical tool 1300 is in use, urging the suture guide release button1316 inwardly 1335 will tend to release the engagement ofcircumferential edges 1324 and 1326 from the extended guide shaft relief1312 so that the suture guide shaft 1311 can slide longitudinally anddistally within cannula 1310. If the suture guide release button 1316 isthereafter released, when suture guide release 1314 arrives at thedetent shaft aperture 1328, the action of detent spring 1318 will urgethe detent shaft into engagement with retracted relief 1314. Thiscorresponds to the action of the surgical tool, as described above.

FIG. 14 shows, in schematic perspective view, another aspect of asurgical tool 1400 prepared according to principles of the invention.The surgical tool 1400 includes a handle member 1402. Disposed withinthe handle member 1402 is a detent mechanism 1404. A longitudinal axis1406 is common to the handle member 1402, a cannular anchor driver 1408and a suture guide shaft 1410 disposed within a cannula of the cannularanchor driver 1408.

The detent mechanism 1404 includes a detent member 1412 with a sutureguide release button 1414 a detent shaft 1416 detent spring 1418 and asuture guide aperture 1420. In the manner discussed above, the sutureguide aperture 1420 embodies edges 1422 that interfere with andtemporarily capture corresponding edges e.g., 1424, 1426 of an extendedsuture guide relief 1428, and a retracted suture guide relief (notvisible).

It will be noted that, in contrast to surgical tool 1300 of FIG. 13 ,detent spring 1418 of surgical tool 1400 is disposed relatively distalto release button 1414 of detent member 1412, as compared to detentspring 1318 and release button 1316.

Handle member 1402 also includes first 1430 and second 1432 distal jawmembers. Distal jaw members 1430 and 1432 are disposed within respectiverecesses 1434, 1436 of handle member 1402. The jaw members 1430 and 1432have respective contact surface regions 1438, 1440. In the illustratedembodiment, cannular anchor driver 1408 includes jaw apertures, e.g.1442.

In certain embodiments of the invention, distal jaw members 1430 and1432 tend to impinge within the jaw apertures, e.g. 1442, to retaincannular anchor driver 1408 longitudinally and rotationally in placewithin the handle member 1402. In such embodiments, cannular anchordriver 1408 may be removably installed within handle member 1402 andsecurely retained therein during operation of the surgical tool 1400.

In certain embodiments, the contact surface regions 1438 and 1440 arearranged to impinge on an external circumferential surface region ofsuture guide shaft 1410, thereby providing a desirable resistance torotation of the suture guide shaft 1410 with respect to handle member1402 while still allowing the suture guide shaft to rotate.

In various embodiments of the invention, the distal jaw members 1430 and1432 include one or more of an elastomeric polymer material, athermoplastic polymer material, a thermoset polymer material, and ametallic material. In other embodiments, other materials will beemployed to achieve desirable characteristics to achieve the functionsdescribed above.

A method according to principles of the invention includes:

-   -   1. Place sutures through the targeted tissue as required.    -   2. Create a hole to accommodate the selected diameter anchor to        the proper depth using a purpose designed drill bit and guide.        The guide may or may not be required.    -   3. Aseptically open the driver and anchor and place the anchor        onto the driver.    -   4. Thread previously placed sutures placed through the Suture        Guide located on the distal end of the driver.    -   5. Insert the Suture Guide with handle into the hole created in        step 2.    -   6. Remove any slack in the suture and create the desired amount        of tension by pulling on the suture tails.    -   7. Push the handle with the anchor firmly into the hole, until        the anchor contacts the suture. This action will maintain the        desired tension on the suture.    -   8. Depress the button on the handle and begin to insert the        anchor into the hole by turning the handle in a clockwise        direction.    -   9. Continue insertion until an audible “click” is heard. This        will signal the proper depth of the implant, which should be        slightly below the surface of the surrounding bone.    -   10. Remove the handle from the implant by pulling it along the        axis of insertion.    -   11. Trim the access suture tails as desired.

While the invention has been described in detail in connection with thepresently preferred embodiments, it should be readily understood thatthe invention is not limited to such disclosed embodiments. Rather, theinvention can be modified to incorporate any number of variations,alterations, substitutions, or equivalent arrangements not heretoforedescribed, but which are commensurate with the spirit and scope of theinvention. Accordingly, the invention is not to be seen as limited bythe foregoing description, but is only limited by the scope of theappended claims.

1. An implant insertion system comprising: a first cannulated shafthaving a first longitudinal axis; a second shaft disposed coaxiallywithin said first cannulated shaft, said second shaft having a proximalend and a distal end; and a suture loop feature, said suture loopfeature being disposed at said distal end of said second longitudinalshaft, said suture loop feature including a body portion having at leastfirst and second surface regions, said first and second surface regionstapering towards said second longitudinal axis in proximity to a distalend of said suture loop feature, said suture loop feature including afirst circumferential edge, a second circumferential edge, and aninternal surface region disposed within said first circumferential edgeand said second circumferential edge, said internal surface regiondefining an eyelet of said suture loop feature through said body portionand generally transverse to said longitudinal axis, said body portionincluding a spine portion disposed adjacent to a first region of saideyelet and a latch portion disposed adjacent to a second region of saideyelet, wherein said latch portion is adapted to flex to transition froma first state in which said eyelet is closed to a second state in whichsaid eyelet is open whereby, in said first state, said eyelet is adaptedto capture a length of suture slidingly therewithin and whereby, in saidsecond state, said eyelet is adapted to release said length of suturefrom said eyelet after said length of suture is disposed within a bone.2. An implant insertion system as defined in claim 1 wherein said eyeletis adapted to be withdrawn through said cannulated shaft along saidfirst longitudinal axis, resulting in said release of said length ofsuture from said eyelet.
 3. An implant insertion system as defined inclaim 1 wherein said suture loop feature is integrally formed with saidsecond shaft.
 4. An implant insertion system as defined in claim 1wherein said eyelet has a generally oval aspect.
 5. An implant insertionsystem comprising: an implant insertion shaft having a proximal end, adistal end and a longitudinal axis disposed between said proximal endand said distal end; and a suture loop feature, said suture loop featurebeing disposed at said distal end of said longitudinal shaft, saidsuture loop feature including a body portion having at least first andsecond external surface regions, said first and second external surfaceregions tapering towards said longitudinal axis in proximity to a distalend of said suture loop feature, said suture loop feature including aninternal surface region defining an aperture of said suture loop featurethrough said body portion and generally transverse to said longitudinalaxis, said body portion including a spine portion disposed adjacent to afirst region of said aperture and a latch portion disposed adjacent to asecond region of said aperture, wherein said latch portion is adapted toflex to transition from a first state in which said aperture is closedto a second state in which said aperture is open whereby, in said firststate, said aperture is adapted to have a length of suture capturedslidingly therewithin and whereby, in said second state, said apertureis adapted to release said length of suture from said aperture aftersaid length of suture is disposed within a substrate.
 6. An implantinsertion system as defined in claim 5 wherein said distal end of saidspine portion extends distally further along said longitudinal axis thansaid distal end of said latch portion.
 7. An implant insertion system asdefined in claim 5 wherein said latch portion is adapted to flex totransition from a first state in which said aperture is closed to asecond state in which said aperture is open and thereafter to returnsubstantially elastically to said first state.
 8. An implant insertionsystem as defined in claim 5 wherein said latch portion is adapted toflex to transition from a first state in which said aperture is closedto a second state in which said aperture is open in response to a forceapplied between said length of suture and said internal surface regionof said aperture.
 9. An implant insertion system as defined in claim 5wherein said implant insertion shaft further comprises a circumferentialshoulder disposed distally of said aperture along said longitudinalaxis, said circumferential shoulder including a generally radial surfaceregion.
 10. An implant insertion system as defined in claim 9 wherein awasher element is disposed coaxially about said implant insertion shaftsuch that a washer surface region of said washer element is adapted tobe supported by said generally radial surface region.
 11. A method ofpreparing an implant insertion system comprising: providing a shaft,said shaft having a proximal end, a distal end, and a longitudinal axis;disposing a spine portion of a suture loop feature proximate to saiddistal end of said shaft, said spine portion of said suture loop featurehaving a first proximal end, a second distal end and a first surfaceregion; disposing a latch portion of said suture loop feature proximateto said distal end of said shaft, said latch portion of said suture loopfeature having a third proximal end, a fourth distal end and a secondsurface region, said third proximal end being connected to said spineportion of said suture loop feature at said first proximal end of saidspine portion; and disposing said fourth distal end of said latchportion in contact with said spine portion such that said first surfaceregion is disposed in spaced relation to said second surface regionacross said longitudinal axis, and such that said contact between saidfourth distal end of said latch portion and said spine portion tends toretain a suture between said first surface region and said secondsurface region.
 12. A method of preparing an implant insertion system asdefined in claim 11 wherein said disposing said spine portion of saidsuture loop feature proximate to said distal end of said shaft comprisesintegrally forming said spine portion of said suture loop featureadjacent to said distal end of said shaft.
 13. A method of preparing animplant insertion system as defined in claim 11 wherein said thirdproximal end of said latch portion being connected to said spine portionof said suture loop feature at said first proximal end of said spineportion comprises said third proximal end being integrally formed withsaid spine portion of said suture loop feature at said first proximalend of said spine portion.
 14. A method of preparing an implantinsertion system as defined in claim 11 wherein said third proximal endof said latch portion being connected to said spine portion of saidsuture loop feature at said first proximal end of said spine portioncomprises forming said latch portion as a discrete component andthereafter coupling said latch portion to said spine portion of saidsuture loop feature.
 15. A method of preparing an implant insertionsystem as defined in claim 11 wherein said disposing said fourth distalend of said latch portion in contact with said spine portion comprisesbending said latch portion towards said longitudinal axis.
 16. A methodof preparing an implant insertion system as defined in claim 11 whereinsaid disposing said fourth distal end of said latch portion in contactwith said spine portion comprises bending said latch portion into asubstantially concave curve with respect to said longitudinal axis. 17.A method of preparing an implant insertion system as defined in claim 11further comprising disposing a washer element coaxially about said shaftdistally of said spine portion.
 18. A method of preparing an implantinsertion system as defined in claim 17 further comprising supportingsaid washer element against distal motion along said longitudinal axisby disposing a distal surface region of said washer element against acorresponding surface region of said shaft.
 19. A method of preparing animplant insertion system as defined in claim 18 wherein saidcorresponding surface region of said shaft comprises a substantiallyradial surface region of said shaft.
 20. A method of preparing animplant insertion system as defined in claim 19 wherein said washerelement is adapted to be released from said shaft during coupling ofsaid suture to a substrate.